Council of the EU Approved Compromise Text of Draft Toy Safety Regulation (TSR)

Current Requirement in TSD

Requirement in TSR (New Added)

1. The directive and its amendments shall be transposed into domestic law by the Member States

1. The regulation and its amendments will apply directly to all Member States

2. EU declaration of conformity (DoC)

2. Digital product passport (DPP)

3. The CE marking, indicating the conformity of a toy, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking should be laid down in the directive

3. Newly added:
(1) Shall be marked on the toy and packaging. Where the toys are sold in a counter display and not able to mark CE on the toy, the counter display shall be marked.
(2) CE mark should be followed by a pictogram or other safety warning

4. Where appropriate for safe use, warnings made for the purposes of Article 10(2) shall specify appropriate user limitations in accordance with Part A of Annex V.
The manufacturer shall mark the warnings in a clearly visible, easily legible, understandable and accurate manner on the toy, on an affixed label or on the packaging and, if appropriate, on the instructions for use which accompany the toy. Small toys which are sold without packaging shall have appropriate warnings affixed to them.
In accordance with Article 4(7), a Member State may, within its territory, stipulate that those warnings and the safety instructions shall be written in a language or languages easily understood by consumers, as determined by that Member State

4. Newly added:
(a) Toys shall bear a general warning (where necessary) specifying appropriate user limitations. The user limitations shall include at least minimum and maximum age, required ability, weight, etc.
(b) Warning shall be clearly visible to the consumers for online sales.
(c) “Warning”; all warnings shall be preceded by the word “Warning” but now this word can be replaced by the Triangle mark (pictogram). Minimum height of pictograms shall be not less than 10 mm

5. The obligations for manufacturers, authorised representatives, importers and distributors are respectively stipulated

5. (a) Emphasising that toys with artificial intelligence (AI) that require third-party conformity assessment are classified as high-risk AI systems under AI Act (Regulation (EU) 2024/1689), Cyber Resilience Act (Regulation (EU) 2024/2847), RED Directive 2014/53/EU, etc. Additionally, interconnected toys with substantial social interactive features (e.g., speaking or filming) or location tracking features are considered important products with digital elements (Class I) and require undergoing a third-party conformity assessment, unless the manufacturer has applied harmonised standards, common specifications or European cybersecurity certification schemes at a “substantial” assurance level

(b) Obligation of the manufacturer and importer

(c) Date Carrier
• The data carrier shall be physically present on the toy or on a label attached to the toy. In case the toy is too small, the data carriers can be on the packaging. But it shall be visible by consumers at the point of sale. Even sell online
• Data carrier for the toy shall be unique
• Consumers shall not be requested to download and install any software, register, or provide a password to access the digital product passport
• The data in DPP shall be stored by the EO responsible for the creation. The other EO shall not be allowed to sell, re-use or process such data
• Before placing the toy on the market, EO shall upload in the union registry and insert a unique product identifier, a unique operator identifier

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6. Take into account the risk posed to mental health, as well as cognitive development of children when use the toys

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7. Adds food imitation, obstruction of intestines and magnets in the essential safety requirements

Current Requirement in TSD

Requirement in TSR

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Electric toys with batteries that constitute small parts shall be designed and manufactured in such a way as to ensure that access to the battery is prevented by requiring the use of a tool. Where the size or nature of the toy so requires, a rechargeable battery may instead be made inaccessible, and removable or replaceable only by independent professionals

Current Requirement in TSD

Requirement in TSR

1. Toys shall not contain substances classified as:
(a) CMR Cat. 1A, 1B, 2 (carcinogenicity, germ cell mutagenicity or reproductive toxicity)

1. Toys shall not contain substances classified as:
(a) CMR Cat. 1A, 1B, 2 (carcinogenicity, germ cell mutagenicity or reproductive toxicity)
(b) ED for human health Cat. 1, 2 (endocrine disruption)
(c) STOT SE/RE Cat. 1 (specific target organ toxicity, single exposure/repeated exposure)
(d) Resp. Sens. Cat. 1 (respiratory sensitization)
(e) Skin Sens. Cat. 1A (skin sensitizers)

2. No specific N-nitrosamines and N-nitrosatable substances limits for slimes and putties

2. N-nitrosamines and N-nitrosatable substances limits in slimes and putties: 0.02 mg/kg and 1 mg/kg respectively

3. TCEP, TCPP, TDCP, formamide, BIT, CMI, phenol, formaldehyde, aniline and BPA requirements apply to toys intended for use by children under 36 months or toys intended to be placed in the mouth

3. TCEP, TCPP, TDCP, formamide, BIT, CMI, phenol, formaldehyde, aniline and BPA requirements apply to all kinds of
toys for children under 14 years old

4. BPA migration limit: 0.04 mg/L

4. BPA migration limit: 0.005 mg/L

5. No monomer migration limits on acrylonitrile, butadiene, styrene and vinyl chloride (VC)

5. Monomer migration limits (acrylonitrile, butadiene, styrene and vinyl chloride (VC)) for polymeric components of all kinds of toys under 14 years old: 0.01 mg/L, 0.07 mg/L, 0.77 mg/L and 0.01 mg/L respectively

6. Allergenic fragrances content limits (or limits to trigger labelling obligation): 100 mg/kg (0.01%) each

6. Allergenic fragrances content limits (or limits to trigger labelling obligation): 10 mg/kg (0.001%) each.
When the labelling obligation is triggered, the information of allergenic fragrances shall also be in the digital product passport (DPP)

7. No specific requirements for toys.
Toys can be treated articles in EU BPR Regulation (EU) 528/2012

7. Toys shall not be biocidal products nor treated articles in EU BPR Regulation (EU) 528/2012 (except toy intended to be permanently placed outdoors or preservatives for certain leave-on cosmetics)

8. No specific PFAS (per- and polyfluoroalkyl substances) requirement for toys.
Toys comply with general CMR requirement, REACH Regulation (EC) No 1907/2006 Annex XVII and SVHC requirements, and POPs Regulation (EU) 2019/1021 requirement

8. Intentional use of PFAS (per- and polyfluoroalkyl substances) in toys is prohibited

9. No specific bisphenols requirement for toys other than BPA (bisphenol A).
Toys comply with general CMR requirement and REACH Regulation (EC) No 1907/2006 SVHC requirement

9. 10 bisphenols are prohibited in toys
(Note: it may extend to 34 bisphenols in the future)

10. No exemption for cobalt (Co)

10. Exempt cobalt (Co) in metal toy components intended to conduct electric current
(Not: it may exempt cobalt (Co) in metal toy components that serve a function other than electrical conductance such as metal toys, toy jewellery, fidget spinners, magnets in the future)

Contact Person

Telephone No.

Email Address

Ms. Lau

(86) 769 87712112 ext. 1719

laulk@dpi-labs.com